In clinical trials, a total of 578 patients received selegiline medication ODT. The most common adverse drug events reported, compared with placebo, were dizziness, nausea, pain, headache, insomnia, rhinitis, dyskinesia, back pain, stomatitis, and dyspepsia. Side effects that prompted discontinuation of therapy included dizziness, chest pain, accidental injury, and myasthenia.

Patients 65 years of age and older experienced a higher frequency of treatment-emergent adverse events, compared with younger patients. The relative risk versus placebo was two-fold or higher for selegiline ODT treatment in geriatric patients, compared with that in nongeriatric patients for hypertension, orthostatic and postural hypotension, dizziness, somnolence, ECG abnormalities, nausea, dyspepsia, abnormal dreams, anxiety, cheilitis, diarrhea, flu syndrome, hyperkalemia, pharyngitis, and infection.

In clinical trials, hallucinations were reported more frequently when selegi-line ODT was used concomitantly with levodopa; 4% of patients using selegiline ODT and 2% of patients receiving placebo reported experiencing this effect. Hallucinations led to drug discontinuations and premature withdrawal from clinical trials in approximately 1% of patients treated with selegiline ODT and in none of the patients receiving placebo. canadian cialis online

The effects of selegiline ODT have not been studied in renally and hepatically impaired patients. It is recommendedthat caution be exercised when this drug is used in patients with these impairments. Discontinuation of selegiline ODT should be considered if these patients experience more frequent or severe adverse reactions than might ordinarily be expected.

CONTRAINDICATIONS

Selegiline ODT is contraindicated with meperidine (Demerol, Sanofi-Synthe-labo), tramadol (Ultram, Ortho-McNeil), methadone, propoxyphene (Darvon, Xanodyne), dextromethorphan, and other selegiline products. The concomitant use of selegiline ODT with these drugs has resulted in reactions characterized by malignant hyperpyrexia, severe hypertension or hypotension, severe respiratory depression, convulsions, excitation, peripheral vascular collapse, coma, and even death. It is recommended that at least 14 days elapse after selegiline ODT is discontinued before any of these other agents is initiated.

DRUG INTERACTIONS

The concomitant use of nonselective MAO inhibitors and selective MAO-B inhibitors, such as selegiline tablets, with tricyclic antidepressants has resulted in CNS toxicity, including mental status changes, muscle rigidity, diaphoresis, hy-pertensi on, hyperpyrexia, syncope and death.

Serious and sometimes fatal reactions have also been reported when a non-selective MAO inhibitor or selegiline was administered with an SSRI such as fluox-etine (Prozac, Eli Lilly) sertraline (Zoloft, Pfizer), or generic paroxetine (Paxil drug, Glaxo-SmithKline) or a serotonin-norepineph-rine reuptake inhibitor (SNRI) such as venlafaxine tablet (Effexor canadian, Wyeth). Signs and symptoms include hyperthermia, rigidity, myoclonus, autonomic instability with rapid vital sign fluctuations, and mental status changes that have progressed to extreme agitation, delirium, and coma.

Because the selectivity of selegiline ODT might not be absolute, even at the recommended 2.5 mg daily, it is prudent to avoid its use with any of the aforementioned antidepressants. It is recommended that at least two weeks elapse after the discontinuation of selegiline ODT before any of these products is initiated, and vice versa. Because of its longer half-life and active metabolite, pa­tients should be instructed to wait five weeks before beginning selegiline ODT therapy after discontinuing fluoxetine.

Drugs that induce CYP 3A4, such as phenytoin (Dilantin, Pfizer), carbamaz-epine (e.g., Carbatrol, Shire; Tegretol, Novartis), phenobarbital, and rifampin, should be used with caution, because se-legiline ODT is a substrate of the CYP 3A4 pathway. Drug interaction studies have not been conducted to evaluate the effect of selegiline ODT on other drugs or the effect of other medications on se-legil ine ODT. tadalis sx 20

In addition to increasing the incidence of hallucinations with concomitant levo-dopa use, selegiline may also potentiate the dopaminergic adverse effects of levo-dopa and may cause or exacerbate preexisting dyskinesia. Decreasing the dose of levodopa may lessen this adverse effect .

DOSAGE AND ADMINISTRATION

Selegiline ODT is indicated only as an adjunct in the management of patients with PD who are being treated with levo-dopa/carbidopa and who are experiencing deterioration in the quality of their response to this therapy. There is no evidence to support the use of selegiline ODT in the absence of concurrent levo-dopa therapy.

Selegiline ODT therapy should be initiated at 1.25 mg once daily for six weeks. If the desired effects have not been achieved after six weeks, the dose can then be increased to 2.5 mg daily. There is no evidence to support the use of doses greater than 2.5 mg daily. Because of the increased risk of adverse effects associated with nonselective MAO inhibition, doses that exceed 2.5 mg should be avoided.

Selegiline ODT should be placed on the tongue, where it disintegrates in seconds, and it should be taken in the morning before breakfast without any liquid. Food and liquid ingestion should be avoided for five minutes before and after patients take selegiline ODT.

Patients should be instructed to peel the backing of the blister pack and not to push the tablet through the foil backing. They should also be shown how to handle the drug with dry hands and to gently remove the tablet.
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COST

Zelapar is available only in a Zydis formulation. Each carton contains 60 tablets. Ten tablets are contained in a moisture-resistant pouch and are packaged in a carton, with six pouches in each carton. Neither the blister card nor the pouch is child-resistant.

In November 2007, the average wholesale price of selegiline ODT for a carton of 60 tablets was $289.69; a bottle of 60 conventional selegiline HCl tablets was $126.10. Because selegiline ODT costs more than double the price of conventional selegiline tablets, patients should discuss the cost with their health care providers if they feel that the ODT formulation is a better option for them.

CONCLUSION

Currently, no cure for Parkinson’s disease exists. As our baby-boomer generation continues to age and the prevalence of PD increases, it is crucial that medications be made available for these patients to alleviate symptoms of this debilitating disease. Selegiline HCl has been used for many years as an adjunct for PD patients who experience a decreased response to levodopa’s effects. Selegiline ODT (Zelapar) is a viable and desirable new option, because it addresses the common complication of dysphagia and improves the quality of life for patients with its quick onset of action. Its new pharmacokinetic profile obviates first-pass metabolism, resulting in higher se-legi- ine concentrations and lower metabolite levels, compared with conventional selegiline tablets, without an increased incidence of adverse effects.
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Because there is no cure, much of our pharmacological therapy is aimed at improving the quality of life in patients with PD. For these patients, off times have a tremendous negative impact on the quality of their lives. Zelapar orally disintegrating tablets significantly decrease symptoms and offtime.